Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes

Corresponding Author: Victor G. Vogel, MD, MHS, Magee-Womens Hospital, University of Pittsburgh School of Medicine, 300 Halket St, Room 3524, Pittsburgh, PA 15213-3221 ([email protected]).

Published Online: June 5, 2006 (doi:10.1001/jama.295.23.joc60074).

Author Contributions: Dr Costantino had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Vogel, Costantino, Wickerham, Cronin, Robidoux, Lippman, Runowicz, Ford, Jordan, Wolmark.

Acquisition of data: Vogel, Costantino, Cronin, Atkins, Bevers, Fehrenbacher, Pajon, Wade, Robidoux, Margolese, James, Ganz, McCaskill-Stevens.

Analysis and interpretation of data: Vogel, Costantino, Cronin, Cecchini, Robidoux, Lippman, Ganz, Reis, Ford, Wolmark.

Drafting of the manuscript: Vogel, Costantino, Cronin, Cecchini, Robidoux.

Critical revision of the manuscript for important intellectual content: Vogel, Costantino, Wickerham, Cronin, Atkins, Bevers, Fehrenbacher, Pajon, Wade, Robidoux, Margolese, James, Lippman, Runowicz, Ganz, Reis, McCaskill-Stevens, Ford, Jordan, Wolmark.

Statistical analysis: Costantino, Cecchini.

Obtained funding: Costantino, Cronin, McCaskill-Stevens, Jordan.

Administrative, technical, or material support: Vogel, Costantino, Wickerham, Cronin, Atkins, Bevers, Wade, Robidoux, Margolese, James, Ganz, Reis, Ford, Wolmark.

Study supervision: Vogel, Costantino, Cronin, Bevers, Fehrenbacher, Pajon, Lippman, Ford, Wolmark.

Financial Disclosures: Dr Vogel reports having served on the speaker's bureau and as a consultant for, and having received honoraria from, Eli Lilly and AstraZeneca. Dr Wickerham reports having served on the speaker's bureau for, and having received honoraria from, AstraZeneca. Dr Cronin reports having served on the Adherence Advisory Board for AstraZeneca. Dr Margolese reports having served on the speaker's bureau for AstraZeneca. Dr Wolmark reports having received honoraria from Eli Lilly. No other authors reported disclosures.

Active NSABP STAR P-2 Clinical Centers as of May 3, 2006: United States:Albert Einstein Comprehensive Cancer Center of Montefiore Medical Center, Bronx, NY: Joseph Sparano (Principal Investigator [PI]), Una Hopkins (Project Coordinator [PC]); Albert Einstein Healthcare Network, Philadelphia, Pa: Ajit M. Desai (PI), Mary P. Murphy (PC); Allegheny Cancer Center Protocol Office, Pittsburgh, Pa: Norman Wolmark (PI), Deborah S. Davison (PC); Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital & Washington University School of Medicine, St Louis, Mo: Antonella L. Rastelli (PI), Gwendolyn Randall (PC); Arizona Cancer Center, Tucson: David S. Alberts (PI), Heidi Fritz (PC); Aultman Hospital, Canton, Ohio: Eleftherios Paul Mamounas (PI), Nancy E. Hansen (PC); Baltimore-Washington Regional STAR Center, Baltimore, Md: John L. Zapas (PI), Sally Brown (PC); Baptist Cancer Institute, Jacksonville, Fla: Neil Abramson (PI), Andrea B. Canto (PC); Baptist Clinical Research Center, Memphis, Tenn: Lee S. Schwartzberg (PI), Patricia M. Gish (PC); Baptist Hospital East/CBC, Louisville, Ky: Daniel C. Scullin, Jr (PI), Judy E. Sisk (PC); Bassett Healthcare, Cooperstown, NY: Anne N. Nafziger (PI), Jennifer M. Victory (PC); Baylor College of Medicine, Houston, Tex: Powel H. Brown (PI), Toni E. Sinclair (PC); Baylor-Sammons Cancer Center, Dallas, Tex: Michael D. Grant (PI), Elaine Lagow (PC); Berkshire Hematology Oncology, PC, Pittsfield, Mass: Harvey Zimbler (PI), Gloria F. Gero (PC); Beth Israel Deaconess Medical Center, Boston, Mass: Nadine Tung (PI), Rena Leib (PC); Boca Raton Community Hospital, Boca Raton, Fla: Louise E. Morrell (PI), Mary Klaus-Clark (PC); CAMC Health Education and Research Institute Center for Cancer Research, Charleston, WVa: Steven J. Jubelirer (PI), Augusta Kosowicz (PC); Cancer Research Network Inc, Plantation, Fla: Charles L. Vogel (PI), Filiz Gokce (PC); CCOP Cancer Research for the Ozarks, Springfield, Mo: J. Wendall Goodwin (PI), Deborah A. Cane (PC); CCOP Cedar Rapids Oncology Project-Mercy Medical Center, Cedar Rapids, Iowa: Abby R. Thrower (PI), Kathy V. Fleming (PC); CCOP Marshfield Clinic, Marshfield, Wis: James L. Hoehn (PI), Kelly J. Noreen (PC); CCOP Alton Ochsner Medical Foundation, New Orleans, La: Carl G. Kardinal (PI), Kate Rodger (PC); CCOP Atlanta Regional, Atlanta, Ga: Janice Galleshaw (PI), Karen E. Packard (PC); CCOP Benaroya Research Institute at Virginia Mason, Seattle, Wash: Andrew D. Jacobs (PI), Cathleen Goetsch (PC); CCOP Carle Cancer Center, Urbana, Ill: Kendrith M. Rowland (PI), Shelly B. McCaskill (PC); CCOP Central Illinois, Decatur, Ill: James Lloyd Wade III (PI), Peggy S. Verrill (PC); CCOP Christiana Care Health Services, Newark, Del: Timothy Francis Wozniak (PI), Pamela G. Eppes (PC); CCOP Colorado Cancer Research Program, Denver: Eduardo R. Pajon, Jr (PI), Robin Szekely (PC); CCOP Columbia River Oncology Program, Portland, Ore: Keith S. Lanier (PI), Jenny L. DeKorne (PC); CCOP Columbus, Columbus, Ohio: John Philip Kuebler (PI), Julie O'Brian (PC); CCOP Dayton, Dayton, Ohio: Howard M. Gross (PI), Bernadette L. Bensman (PC); CCOP Duluth Cancer Center, Duluth, Minn: Steven A. Kuross (PI), Becky Buchanan (PC); CCOP Evanston/Highland Park Hospital, Highland Park, Ill: Douglas E. Merkel (PI), Nancy J. Haefling (PC); CCOP Grand Rapids Clinical Oncology Program, Grand Rapids, Mich: Marianne K. Lange (PI), Connie M. Szczepanek (PC); CCOP Greenville, Greenville, SC: Jeffrey K. Giguere (PI), Claudette Phinney (PC); CCOP Heartland Cancer Research: St Louis, Mo: Alan P. Lyss (PI), Rebecca L. Tackett (PC); CCOP Hematology-Oncology Associates of CNY, Syracuse, NY: Jeffrey J. Kirshner (PI), Sue Averson (PC); CCOP Iowa Oncology Research Association, Des Moines: Roscoe F. Morton (PI), Mary L. Loots (PC); CCOP Kalamazoo, Kalamazoo, Mich: Raymond S. Lord III (PI), Joan Westendorp (PC); CCOP Kansas City Clinical Oncology Program, Kansas City, Mo: Rakesh Gaur (PI), Mabel Goodpaster (PC); CCOP Main Line Health, Bryn Mawr, Pa: Thomas G. Frazier (PI), Rosemary Wiggins (PC); CCOP Mayo Clinic Scottsdale, Scottsdale, Ariz: Tom R. Fitch (PI), Kortni R. Jones (PC); CCOP MeritCare Hospital, Fargo, ND: Ralph Levitt (PI), Valorie Steichen (PC); CCOP Metro-Minnesota, St Louis Park, Minn: Patrick James Flynn (PI), Ann Deshler (PC); CCOP Michigan Cancer Research Consortium Community Clinical Onc Program, Ann Arbor: Philip J. Stella (PI), Kathy A. Flynn (PC); CCOP Missouri Valley Cancer Consortium, Omaha, Neb: Gamini Soori (PI), Mary Beth Wilwerding (PC); CCOP Montana Cancer Consortium, Billings: David B. Myers (PI), Shirley Hall (PC); CCOP Nevada Cancer Research Foundation, Las Vegas: John A. Ellerton (PI), Kathleen Van Wagenen (PC); CCOP North Shore University Hospital, Manhasset, NY: Lora R. Weiselberg (PI), Doreen Mayberry (PC); CCOP Northern Indiana Research Consortium, South Bend: Robin T. Zon (PI), Maria Schwieter (PC); CCOP Northern New Jersey/Hackensack University Medical Center, Hackensack: Deborah M. Capko (PI), Kathleen Laico (PC); CCOP Northwest, Tacoma, Wash: Lauren K. Colman (PI), Karyn Hart (PC); CCOP Oklahoma, Tulsa: James B. Lockhart (PI), Kayleen R. Joyce (PC); CCOP Santa Rosa Memorial Hospital, Santa Rosa, Calif: Ian C. Anderson (PI), Marianne Dias (PC); CCOP Scott and White Hospital, Temple, Tex: Kathy Kimmey (PI), Jan P. Pickett (PC); CCOP Sioux Community Cancer Consortium/SDHRF, Sioux Falls, SD: Loren K. Tschetter (PI), Judy Norman (PC); CCOP South Florida STAR Group, Miami Beach: Rogerio C. Lilenbaum (PI), Francine Mineau (PC); CCOP Southeast Cancer Control Consortium Inc, Winston-Salem, NC: James N. Atkins (PI), Robin Burgess (PC); CCOP St Louis-Cape Girardeau, St Louis, Mo: Bethany Graham Sleckman (PI), Carol J. Antinora (PC); CCOP Toledo Community Hospital Oncology Program, Toledo, Ohio: Paul L. Schaefer (PI), Jeanette M. Ceglio (PC); CCOP Upstate Carolina, Spartanburg, SC: Steven W. Corso (PI), Donna Hewitt (PC); CCOP Western Regional, Phoenix, Ariz: David K. King (PI), Susan Colvin (PC); CCOP Wichita, Wichita, Kan: Shaker R. Dakhil (PI), Marge J. Good (PC); CCOP William Beaumont Hospital, Royal Oak, Mich: David A. Decker (PI), Jeanne Archer (PC); City of Hope National Medical Center, Duarte, Calif: Lawrence D. Wagman (PI), Annette S. Brown (PC); Clarian Health Partners Inc, Indianapolis, Ind: Anna Maria V. Storniolo (PI), Jane V. Berby-Todd (PC); Cleveland Clinic Health System Star BCPT, Warrensville Heights, Ohio: Roger F. Classen (PI), Alice Somich (PC); Coborn Cancer Center, St Cloud, Minn: Harold E. Windschitl (PI), Linda Meehl (PC); Columbia University Medical Center, New York, NY: Victor R. Grann (PI), Rossy Sandoval (PC); Comprehensive Cancer Institute, Huntsville, Ala: Jeremy K. Hon (PI), Susan C. Meyer (PC); Connecticut BCPT Task Force, Hartford: Patricia A. DeFusco (PI), Camille Alyce Servodidio (PC); Dana-Farber Cancer Institute, Boston, Mass: Judy E. Garber (PI), Jennifer Thibodeau (PC); Desert Regional Medical Center, Palm Springs, Calif: Janet K. Ihde (PI), Gregory S. Jackson (PC); Don and Sybil Harrington Cancer Center, Amarillo, Tex: Brian Pruitt (PI), Kathy Morris (PC); Duke University Medical Center, Durham, NC: Paul K. Marcom (PI), Donna C. Harper (PC); East Carolina University, Greenville, NC: Rosa Cuenca (PI), Melinda F. Friday (PC); Eastern Cooperative Onc Group/National Medical Association, Philadelphia, Pa: Edith P. Mitchell (PI), Charmaine Green (PC); Eastern Maine Medical Center, Bangor: A. Merrill Garrett (PI), Laurie Lewis (PC); Ellis Fischel Cancer Center, Columbia, Mo: Edward R. Sauter (PI), Marta L. Fuemmeler (PC); Fox Chase Cancer Center, Philadelphia, Pa: Mary B. Daly (PI), Joan James (PC); Fred Hutchinson Cancer Research Center, Seattle, Wash: Richard B. Clarfeld (PI), Joelle Machia (PC); Geisinger Breast Clinic, Danville, Pa: James F. Evans (PI), Marie Lamey (PC); Glendale Memorial Hospital Comprehensive Cancer Center, Glendale, Calif: Deanna Attai (PI), Mary M. Eichenhofer (PC); Greenebaum Cancer Center, Baltimore, Md: Barry R. Meisenberg (PI), Nancy S. Tait (PC); H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla: Susan Minton (PI), Pamela Dawson (PC); Harris Methodist Fort Worth, Fort Worth, Tex: Mark W. Redrow (PI), Tamara D. Plant (PC); Hendrick Cancer Center, Abilene, Tex: Victor J. Hirsch (PI), Jo Ann Jameson (PC); Hennepin County Medical Center, Minneapolis, Minn: Richard T. Zera (PI), Carol A. Schmidt (PC); Huntsman Cancer Institute at the University of Utah, Salt Lake City: John Harris Ward (PI), Chaunda L. Biggs (PC); Indiana Community Cancer Care, Indianapolis: William M. Dugan, Jr (PI), Carolyn Rhoton (PC); Ireland Cancer Center at Case Western Reserve University, Cleveland, Ohio: Rosemary A. Leeming (PI), Cheryl B. Henkin (PC); Joe Arrington Cancer Research and Treatment Center, Lubbock, Tex: Paul J. Anderson (PI), Vickie Reynolds (PC); Kaiser Permanente San Diego, San Diego, Calif: Jonathan Polikoff (PI), Carol P. Elliott (PC); Kaplan Comprehensive Cancer Center at NYU Medical Center, New York, NY: Anna Pavlick (PI), Karen Carapetyan (PC); Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pa: Bruce M. Boman (PI), Colleen M. Cohick (PC); Lehigh Valley Hospital, John and Dorothy Morgan Cancer Center, Allentown, Pa: Gregory R. Harper (PI), Deborah R. Kane (PC); Loma Linda University Cancer Institute, Loma Linda, Calif: Carlos A Garberoglio (PI), Pedro Bernal (PC); Lombardi Cancer Center, Washington, DC: Claudine Isaacs (PI), Joy Dritschilo (PC); Loyola-Cardinal Bernardin Cancer Center, Maywood, Ill: Kathy Albain (PI), Kathy O'Day (PC); Mayo Clinic Rochester, Rochester, Minn: Sandhya Pruthi (PI), Jean M. Jensen (PC); MBCCOP Gulf Coast, Mobile, Ala: Paul O. Schwarzenberger (PI), Carolyn A. Robinson (PC); MBCCOP Howard University Cancer Center, Washington, DC: Lucile L. Adams-Campbell (PI), Joan Pearson (PC); MBCCOP Louisiana State University Health Sciences Center, New Orleans: Julia A. Lawrence (PI), Tasha N. Moore (PC); MBCCOP Our Lady of Mercy Medical Center, Bronx, NY: Janice Dutcher (PI), Maria Serrano (PC); MBCCOP San Juan, San Juan, Puerto Rico: William Caceres (PI), Doris Cuadrado (PC); MBCCOP University of Hawaii, Honolulu: Nancy L. Furumoto (PI), Ann M. Kelminski (PC); MBCCOP University of Illinois at Chicago (UIC): Divyesh G. Mehta (PI), Judith Murray (PC); MBCCOP University of New Mexico Cancer Research and Treatment Center, Albuquerque: Aroop Mangalik (PI), Ann W. Parsons (PC); MBCCOP Virginia Commonwealth University, Richmond: Mary Helen Hackney (PI), Gwendolyn G. Parker (PC); Memorial Sloan-Kettering Cancer Center, New York, NY: Leslie Montgomery (PI), Yong Anna Park (PC); Mercy Cancer Center, Scranton, Pa: Martin Hyzinski (PI), Vee A. Pauli (PC); Methodist Cancer Center Omaha, Omaha, Neb: Stephen J. Lemon (PI), Kathy Christiansen (PC); Michigan State University, East Lansing: Carol A. Slomski (PI), Cheryl Robins (PC); Mid-Delta Family Practice Clinic II Inc, Cleveland, Miss: Nathaniel Brown (PI), Sarah L. Cooks (PC); Milwaukee Prevention Trial Sinai Samaritan Medical Center MIL, Waukesha, Wis: Paul J. LeMarbre (PI), Julie Fries (PC); Naval Medical Center San Diego, San Diego, Calif: Preston S. Gable (PI), Debbie A. Vacek (PC); Norris Cotton Cancer Center at the Dartmouth-Hitchcock Medical Center, Lebanon, NH: Bradley A. Arrick (PI), Jo A. Strohbehn (PC); North Idaho Cancer Risk Assessment Clinic–NICRAC Coeur D, Alene: Haluk Tezcan (PI), Tolli J. Willhite (PC); North Mississippi Medical Center, Tupelo: Charles W. Montgomery (PI), Linda M. Roof (PC); Northern California Kaiser Permanente Divison of Research, Oakland: Louis Fehrenbacher (PI), Roberta Gross (PC); Northwestern Memorial Hospital, Chicago, Ill: Seema A. Khan (PI), Rachel Cohn (PC); NortonHealthcare Inc, Louisville, Ky: John T. Hamm (PI), Belma Kantardzic (PC); Ohio State University/James CHRI, Columbus: William B. Farrar (PI), Beth A. Putz (PC); Oklahoma NSABP Consortium, Oklahoma City: Karl K. Boatman (PI), Glenda J. Bell (PC); Oregon Health and Science University, Portland: Rodney F. Pommier (PI), Paula Fry (PC); Providence Hospital Cancer Center, Southfield, Mich: Judie R. Goodman (PI), Jaswinder Grewal (PC); Radiant Research, Stuart, Fla: Darrell N. Fiske (PI), Diane Andersen (PC); Rapid City Regional Oncology Group, Rapid City, SD: Richard Charles Tenglin (PI), Beth A. Bement-Stump (PC); Resurrection Medical Center, Chicago, Ill: Adrian Bianco (PI), Mary Ann J. Kosic (PC); Roswell Park/WNY STAR Consortium, Buffalo, NY: Stephen B. Edge (PI), Susan G. Wood (PC); Rush University Medical Center, Chicago, Ill: Janet M. Wolter (PI), Yelizaveta Yanovskaya (PC); Saint Barnabas Health Care System Consortium, Newark, NJ: Frederick B. Cohen (PI), Luzminda B. Costin (PC); San Gabriel Clinical Oncology Research Program, Pasadena, Calif: Benjamin T. Stafford (PI), Maria Francisco-Arriola (PC); Scripps-Stevens Cancer Center, San Diego, Calif: Joel I. Bernstein (PI), Melba Nelson (PC); St Luke's Breast Care Center, Chesterfield, Mo: David P. Krajcovic (PI), Margaret A. Klass (PC); St Vincent's Hospital-Manhattan, New York, NY: Stephanie F. Bernik (PI), Bethany S. Gourley (PC); St Mary Medical Center/Pacific Shores Medical Group, Long Beach, Calif: Nerses Simon Tchekmedyian (PI), Jann E. Buaiz (PC); St Vincent Hospitals and Health Services, Indianapolis, Ind: Ruemu E. Birhiray (PI), Mary Amy Waddell (PC); Stanford University, Palo Alto, Calif: Robert W. Carlson (PI), Christine Schurman (PC); Summa Health System, Akron, Ohio: Ralph Douglas Trochelman (PI), Nancy J. Rinella (PC); SUNY Upstate Medical University, Syracuse, NY: Jayne R. Charlamb (PI), Linda Ellinwood (PC); Sutter Health Cancer Research Group-Eastern Division, Sacramento, Calif: Vincent A. Caggiano (PI), Isabel Rodrigues-Fong (PC); Texas Tech University Health Sciences Center Southwest Cancer Center, Lubbock: Everardo Cobos (PI), Wendy A. Carr (PC); The Cancer Center at Glens Falls Hospital, Glens Falls, NY: Robert W. Sponzo (PI), Barbara A. Sponzo (PC); The Cancer Institute of New Jersey, New Brunswick: Deborah L. Toppmeyer (PI), Angelina G. Owens (PC); The Johns Hopkins Oncology Center, Baltimore, Md: Kala Visvanathan (PI), Sarah Ord (PC); The Regional Cancer Center, Erie, Pa: Roy E. Smith (PI), Lisa Quirk (PC); The Western Pennsylvania Hospital, Pittsburgh: John A. Lech (PI), Laura Getty Gibson (PC); Thompson Cancer Survival Center, Knoxville, Tenn: Daniel Mark Ibach (PI), Josie B. Stanga (PC); UCLA-Center for Health Sciences, Los Angeles, Calif: Patricia A. Ganz (PI), Barbara Kahn (PC); University Hospital & Medical Center at Stony Brook, Stony Brook, NY: Stefan Madajewicz (PI), Gerty Fortune (PC); University of Arkansas for Medical Sciences/Arkansas Cancer Res Center: Little Rock: V. Suzanne Klimberg (PI), Maureen A. Smith (PC); University of California San Diego Cancer Center: Anne M. Wallace (PI), Thuy Pham (PC); University of California, Irvine Medical Center, Orange: Randall F. Holcombe (PI), Brandy Fitzhenry (PC); University of Chicago, Chicago, Ill: Nora T. Jaskowiak (PI), Yolanda M. Davis (PC); University of Cincinnati, Cincinnati, Ohio: Elizabeth A. Shaughnessy (PI), Ruth L. Steele (PC); University of Iowa Hospitals and Clinics, Iowa City: Neal Walter Wilkinson (PI), Michelle Arnold (PC); University of Kansas Medical Center, Kansas City: William R. Jewell (PI), Holly J. Smith (PC); University of Kentucky Medical Center, Lexington: Edward H. Romond (PI), Valorie A. Gray (PC); University of Louisville/Brown Cancer Center, Louisville, Ky: Jeffrey B. Hargis (PI), Jackie H. Sheffield (PC); University of Michigan University Hospital, Ann Arbor: Sofia Merajver (PI), Janet H. Tarolli (PC); University of North Carolina at Chapel Hill, Chapel Hill: Stephen A. Bernard (PI), Nancy Pope (PC); University of Pittsburgh Medical Center Health Systems, Pittsburgh, Pa: Victor G. Vogel (PI), Marsha MacIntyre (PC); University of Tennessee Medical Center, Knoxville: Daniel M. Green (PI), Mary E. Donovan (PC); University of Texas Health Science Center at San Antonio: Morton S. Kahlenberg (PI), Betty Razvillas (PC); University of Texas M. D. Anderson Cancer Center, Houston: Therese B. Bevers (PI), Valerie Sepeda (PC); University of Texas Southwestern Medical Center at Dallas: Ann Marilyn Leitch (PI), Mary E. De Haas (PC); University of Wisconsin Comprehensive Cancer Center, Madison: James A. Stewart (PI), Mary Hamielec (PC); URCC Cancer Prevention Network, Rochester, NY: Gary R. Morrow (PI), Kelly A. Kita (PC); USC/Norris Cancer Center, Los Angeles, Calif: Darcy V. Spicer (PI), Elizabeth M. Sales (PC); Valley Hospital, Ridgewood, NJ: Harold Bruck (PI), Melissa F. Cooper (PC); Vanderbilt Cancer Center, Nashville, Tenn: Mark Kelley (PI), Elizabeth Broome (PC); Vassar Brothers Hospital, Poughkeepsie, NY: Carol S. Woo (PI), Camille Finkle (PC); Vermont Cancer Center University of Vermont, Burlington: Seth P. Harlow (PI), Karen M. Wilson (PC); Wake Forest University School of Medicine, Winston Salem, NC: Edward A. Levine (PI), Lisa B. Pruitt (PC); Wayne State University Karmanos Cancer Institute, Detroit, Mich: Michael Simon (PI), Mary Akagi (PC); West Florida Cancer Institute, Pensacola: Mark S. Boatright (PI), Laura J. Malek (PC); Wilford Hall Medical Center, Lackland AFB, Tex: Allyson Lynn Harroff (PI), Blanca N. Velazquez (PC); Yakima Valley Memorial Hospital/North Star Lodge Cancer Center, Yakima, Wash: Thomas E. Boyd (PI), Cheryl Hopkins (PC); Yale University School of Medicine-Yale Cancer Center, New Haven, Conn: Donald R. Lannin (PI), Michele D. Alguard (PC); York Cancer Center, York, Pa: Ronald E. Hempling (PI), Debi Oxenberg (PC). Canada:CancerCare Manitoba, Winnipeg: Andrew L. Cooke (PI), Jeannette Kostenuik (PC); Centre Hospitalier Affilie Universitaire de Quebec, Hopital du St-Sacrement, Quebec: Louise Provencher (PI), Guylaine Julien (PC); Cross Cancer Institute, Edmonton, Alberta: Barbara E. Krause (PI), Peggy Blize (PC); Jewish General Hospital, Montréal, Quebec: Richard Gordon Margolese (PI), Linda Robitaille (PC); Le Groupe Hospitalier de l'Universite de Montréal, Montréal, Quebec: Andre Robidoux (PI), Nicole Tremblay (PC); Montreal General Hospital, Montréal, Quebec: Michael P. Thirlwell (PI), Catherine Meaney (PC); Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario: Shailendra Verma (PI), Peggy Florack (PC); Royal Victoria Hospital, Montréal, Quebec: Henry Ryusuke Shibata (PI), Rosalia Santos (PC); St Michael's Hospital Breast Centre, Toronto, Ontario: Jarley Koo (PI), Daisy J. Dastur (PC); Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario: Margaret Lyn Anthes (PI), Cindy Sinnott (PC); Tom Baker Cancer Centre, Calgary, Alberta: Alexander H. G. Paterson (PI), Barb Gore-Hickman (PC); UBC-Vancouver Hospital & Health Science Center, Vancouver, British Columbia: Urve Kuusk (PI), Lynn Fearn (PC); Women's College Campus, Toronto, Ontario: H. Lavina A. Lickley (PI), Maria Oldfield (PC).

Funding/Support: This study was supported by Public Health Service grants U10-CA-37377, U10-CA-69974, U10CA-12027, and U10CA-69651 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services; and by AstraZeneca Pharmaceuticals and Eli Lilly and Co.

Role of the Sponsor: The study sponsors had no role in any aspect of study design; in the collection, analysis, and interpretation of data; or in the development of the manuscript. Per contractual arrangement, the manuscript was submitted to AstraZeneca and Eli Lilly before submission.

Acknowledgment: We thank Barbara C. Good, PhD, Director of Scientific Publications for the NSABP, for editorial assistance and Lynne Anderson, Biostatistical Center, NSABP, for her valuable assistance in the conduct of the study.